CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 100 enrolled
Drug / intervention
Tedizolid phosphate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03176134
NCT03176134Phase 3Completed

A Phase III Randomized, Active-comparator-Controlled Clinical Trial to Study the Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator, in Subjects From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Merck Sharp & Dohme LLC·interventional·Posted Jun 5, 2017·Updated Jul 31, 2025

In Brief

A Phase 3 clinical trial evaluating Tedizolid phosphate and Comparator for Acute Bacterial Skin and Skin Structure Infections. Completed, enrolled 100 participants across 58 sites in 14 countries.

Detailed Summary

This study will evaluate the safety, tolerability, and efficacy of tedizolid phosphate (MK-1986) compared with comparator antibacterial agent in participants from birth to less than 12 years of age with acute bacterial skin and skin structure infections (ABSSSI).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil, Bulgaria, Georgia, Germany, Guatemala, Latvia, Lithuania, Mexico, Poland, Russia, South Africa, Turkey (Türkiye), Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJun 5, 2017
Enrollment StartJan 20, 2019
Primary CompletionJul 6, 2023
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 9.1 years ago

Interventions

Tedizolid phosphatedrug

Tedizolid phosphate IV solution or oral suspension

Comparatordrug

Vancomycin IV, linezolid IV or oral (outside European Union only), clindamycin IV or oral, flucloxacillin IV or oral, cefazolin IV, or cephalexin oral provided locally by the trial site and administered per local standard of care